Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

• Drug: sunitinib
  Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
  Other Name: Sutent, SU011248
• Drug: mFOLFOX6
  FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m^2 + leucovorin 400 mg/ m^2 (or 200 mg/ m^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
• Drug: bevacizumab
  Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
  Other Name: Avastin

• Experimental: A
  Treatment arm A - sunitinib plus mFOLFOX6
  Interventions:

  • Drug: sunitinib
  • Drug: mFOLFOX6
• Active Comparator: B
  Treatment arm B - bevacizumab plus mFOLFOX6
  Interventions:

  • Drug: bevacizumab
  • Drug: mFOLFOX6

Inclusion Criteria:

• Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
• Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

• Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
• Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
• History of cardiac disease
• Brain mets